ULTRACARE ORAL ANESTHETIC ORANGE CREAM- benzocaine gel

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)

Prieinama:

Ultradent Products, Inc

INN (Tarptautinis Pavadinimas):

Benzocaine

Sudėtis:

Benzocaine 231 mg in 1 mL

Vartojimo būdas:

DENTAL

Recepto tipas:

OTC DRUG

Terapinės indikacijos:

Oral Anesthetic For the temporary relief of occasional minor irritation and pain associated with - minor dental procedures - sore mouth and throat - minor injury of the gums - canker sores - minor irritation of the mouth or gums caused by dentures or orthodontic appliances.

Autorizacija statusas:

OTC monograph not final

Pakuotės lapelis

Ultradent Products, Inc
Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if
they comply with applicable regulations and policies. FDA has not
evaluated whether this product
complies.
----------
Ultracare®
ORAL ANESTHETIC GEL
Description:
Ultracare is a 20% w/v (17.9%) benzocaine oral anesthetic gel
preparation in a water-soluble glycol base.
Ultracare is designed for rapid onset (10-30 seconds). Anesthesia
usually lasts 8-10 minutes. Ultracare is
NOT for injection.
Uses:
For the temporary relief of occasional minor irritation and pain,
associated with:
•
Minor dental procedures
•
Sore mouth and throat
•
Minor injury of the gums
•
Canker sores
•
Minor irritation of the mouth or gums caused by dentures or
orthodontic appliances
Warnings:
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious condition
that must be treated promptly
because it reduces the amount of oxygen carried in blood. This can
occur even if you have used this
product before. Stop use and seek immediate medical attention if you
or a child in your care develops:
•
pale, gray, or blue colored skin (cyanosis)
•
headache
•
rapid heart rate
•
shortness of breath
•
dizziness or lightheadedness
•
fatigue or lack of energy.
For external use only
Allergy alert:
Do not use if you have a history of allergy to local anesthetics such
as procaine, butacaine, benzocaine or
other "caine" anesthetics, PABA compounds, or sunscreen. If a skin
reaction occurs, stop use and seek
medical help right away.
Sore throat warning:
If sore throat is severe, persists for more than 2 days, is
accompanied or followed by fever, headache,
rash, swelling, nausea, or vomiting, consult a doctor promptly. If
sore mouth symptoms do not improve in
7 days, or if irritation, pain, or redness persist or worsens, see
your dentist or doctor promptly.
Procedure:
1.
Preloaded 1.2ml syringes:
a.
Remove luer lock cap from syringe.
b.
Attach a Blue Micro® 20-gauge Tip or 5mm Micro
Capillary Tip se

Prekės savybės

ULTRACARE ORAL ANESTHETIC ORANGE CREAM- BENZOCAINE GEL
ULTRADENT PRODUCTS, INC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
----------
ULTRACARE ORAL ANESTHETIC GEL ORANGE CREAM
_DRUG FACTS_
ACTIVE INGREDIENT
Benzocaine 20% w/v
PURPOSE
Oral Anesthetic
USES
For the temporary relief of occasional minor irritation and pain
associated with
minor dental procedures
sore mouth and throat
minor injury of the gums
canker sores
minor irritation of the mouth or gums caused by dentures or
orthodontic appliances.
WARNINGS
METHEMOGLOBINEMIA WARNING
Use of this product may cause methemoglobinemia, a serious condition
that must be
treated promptly because it reduces the amount of oxygen carried in
blood. This can
occur even if you have used this product before.
Stop use and seek immediate medical attention if you or a child in
your care develops:
pale, gray, or blue colored skin (cyanosis)
headache
rapid heart rate
shortness of breath
dizziness or lightheadedness
fatigue or lack of energy.
FOR EXTERNAL USE ONLY
ALLERGY ALERT
®
Do not use if you have a history of allergy to local anesthetics such
as procaine,
butacaine, benzocaine or other "caine" anesthetics, PABA compounds, or
sunscreen. If
a skin reaction occurs, stop use and seek medical help right away.
SORE THROAT WARNING
if sore throat is severe, persists for more than 2 days, is
accompanied or followed by
fever, headache, rash, swelling, nausea, or vomiting, consult a doctor
promptly. If sore
mouth symptoms do not improve in 7 days, or if irritation, pain, or
redness persist or
worsens, see your dentist or doctor promptly.
DO NOT USE
if taking sulfonamides
for teething
in children under 2 years of age
WHEN USING THIS PRODUCT
avoid contact with eyes.
KEEP OUT OF REACH OF CHILDREN. in case of overdose, get medical help
or contact a
Poison Control Center right away. Do not exceed recommended dosage.
DIRECTIONS
A